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What is Xeljanz/Xeljanz XR?

Xeljanz/Xeljanz XR is a prescription medicine called a Janus kinase (JAK) inhibitor. Xeljanz/Xeljanz XR is used to treat adults with moderately to severely active rheumatoid arthritis in whom methotrexate did not work well or cannot be tolerated.

Xeljanz/Xeljanz XR is used to treat adults with active psoriatic arthritis in which methotrexate or other similar medicines called nonbiologic disease-modifying antirheumatic drugs (DMARDs) did not work well or cannot be tolerated.

Xeljanz is used to treat adults with moderately to severely active ulcerative colitis when medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated.

It is not known if Xeljanz/Xeljanz XR is safe and effective in people with Hepatitis B or C.

Xeljanz/Xeljanz XR is not recommended for people with severe liver problems.

It is not known if Xeljanz/Xeljanz XR is safe and effective in children.

What is the most important information I should know about Xeljanz/Xeljanz XR?

Xeljanz/Xeljanz XR may cause serious side effects including:

1. Serious infections. Xeljanz/Xeljanz XR is a medicine that affects your immune system. Xeljanz/Xeljanz XR can lower the ability of your immune system to fight infections. Some people can have serious infections while taking Xeljanz/Xeljanz XR, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.

Your healthcare provider should test you for TB before starting Xeljanz/Xeljanz XR and during treatment.

Your healthcare provider should monitor you closely for signs and symptoms of TB infection during treatment with Xeljanz/Xeljanz XR.

You should not start taking Xeljanz/Xeljanz XR if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster).

People taking the higher dose (10 mg twice daily) of Xeljanz have a higher risk of serious infections and shingles.

have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections.

have TB, or have been in close contact with someone with TB.

live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use Xeljanz/Xeljanz XR. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.

have or have had hepatitis B or C.

After starting Xeljanz/Xeljanz XR, call your healthcare provider right away if you have any symptoms of an infection. Xeljanz/Xeljanz XR can make you more likely to get infections or make worse any infection that you have.

2. Increased risk of death in people 50 years of age and older with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of Xeljanz/Xeljanz XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is Xeljanz 5 mg twice daily or Xeljanz XR 11 mg one time each day.

3. Cancer and immune system problems. Xeljanz/Xeljanz XR may increase your risk of certain cancers by changing the way your immune system works.

Lymphoma and other cancers including skin cancers can happen in patients taking Xeljanz/Xeljanz XR. People taking the higher dose (10 mg twice daily) of Xeljanz have a higher risk of skin cancers. Tell your healthcare provider if you have ever had any type of cancer.

Some people who have taken Xeljanz with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus-associated post-transplant lymphoproliferative disorder).

4. Blood clots in the lungs, veins of the legs or arms, and arteries. Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT) and arteries (arterial thrombosis) have happened more often in patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of Xeljanz/Xeljanz XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is Xeljanz 5 mg twice daily or Xeljanz XR 11 mg one time each day. Blood clots in the lungs have also happened in patients with ulcerative colitis. Some people have died from these blood clots.

Stop taking Xeljanz/Xeljanz XR and tell your healthcare provider right away if you develop signs and symptoms of a blood clot, such as sudden shortness of breath or difficulty breathing, chest pain, swelling of the leg or arm, leg pain or tenderness, or redness or discoloration in the leg or arm.

5. Tears (perforation) in the stomach or intestines.

Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking Xeljanz/Xeljanz XR can get tears in their stomach or intestines. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have fever and stomach-area pain that does not go away, and a change in your bowel habits.

6. Allergic reactions.

Symptoms such as swelling of your lips, tongue, or throat, or hives (raised, red patches of skin that are often very itchy) that may mean you are having an allergic reaction have been seen in patients taking Xeljanz/Xeljanz XR. Some of these reactions were serious. If any of these symptoms occur while you are taking Xeljanz/Xeljanz XR, stop Xeljanz/Xeljanz XR and call your healthcare provider right away.

7. Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start receiving Xeljanz/Xeljanz XR and while you take Xeljanz/Xeljanz XR to check for the following side effects:

changes in lymphocyte counts. Lymphocytes are white blood cells that help the body fight off infections.

low neutrophil counts. Neutrophils are white blood cells that help the body fight off infections.

low red blood cell count. This may mean that you have anemia, which may make you feel weak and tired.

Your healthcare provider may stop your Xeljanz/Xeljanz XR treatment for a period of time if needed because of changes in these blood test results.

You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start receiving Xeljanz/Xeljanz XR, and as needed after that. Normal cholesterol levels are important to good heart health.

have had blood clots in the veins of your legs, arms, or lungs, or clots in the arteries in the past.

have liver problems.

have kidney problems.

have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines.

have had a reaction to tofacitinib or any of the ingredients in Xeljanz/Xeljanz XR.

have recently received or are scheduled to receive a vaccine. People who take Xeljanz/Xeljanz XR should not receive live vaccines. People taking Xeljanz/Xeljanz XR can receive non-live vaccines.

plan to become pregnant or are pregnant. Xeljanz/Xeljanz XR may affect the ability of females to get pregnant. It is not known if this will change after stopping Xeljanz/Xeljanz XR. It is not known if Xeljanz/Xeljanz XR will harm an unborn baby.

Pregnancy Registry: Pfizer has a registry for pregnant women who take Xeljanz/Xeljanz XR. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking Xeljanz/Xeljanz XR, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll.

If you plan to breastfeed or are breastfeeding. You and your healthcare provider should decide if you will take Xeljanz/Xeljanz XR or breastfeed. You should not do both. After you stop your treatment with Xeljanz/Xeljanz XR do not start breastfeeding again until:

18 hours after your last dose of Xeljanz or

36 hours after your last dose of Xeljanz XR

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Xeljanz/Xeljanz XR and other medicines may affect each other causing side effects.

What are possible side effects of Xeljanz/Xeljanz XR?

Hepatitis B or C activation infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use Xeljanz/Xeljanz XR. Your healthcare provider may do blood tests before you start treatment with Xeljanz/Xeljanz XR and while you are using Xeljanz/Xeljanz XR. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B or C infection:

feel very tired

little or no appetite

clay-colored bowel movements

chills

muscle aches

skin rash

skin or eyes look yellow

vomiting

fevers

stomach discomfort

dark urine

Common side effects of Xeljanz/Xeljanz XR in rheumatoid arthritis patients and psoriatic arthritis patients include:

upper respiratory tract infections (common cold, sinus infections)

headache

diarrhea

nasal congestion, sore throat, and runny nose (nasopharyngitis)

high blood pressure (hypertension)

Common side effects of Xeljanz in ulcerative colitis patients include:

nasal congestion, sore throat, and runny nose (nasopharyngitis)

increased cholesterol levels

headache

upper respiratory tract infections (common cold, sinus infections)

increased muscle enzyme levels

rash

diarrhea

shingles (herpes zoster)

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Xeljanz/Xeljanz XR. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Pfizer at 1-800-438-1985.

General information about the safe and effective use of Xeljanz/Xeljanz XR

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Xeljanz/Xeljanz XR for a condition for which it was not prescribed. Do not give Xeljanz/Xeljanz XR to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about Xeljanz/Xeljanz XR. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about Xeljanz/Xeljanz XR that is written for health professionals.

How should I store Xeljanz/Xeljanz XR?

Store Xeljanz/Xeljanz XR at room temperature between 68°F to 77°F (20°C to 25°C).

Safely throw away medicine that is out of date or no longer needed.

Keep Xeljanz/Xeljanz XR and all medicines out of the reach of children.